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Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

Primary Purpose

COVID-19, SARS-CoV 2, SARS-CoV Infection

Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
COVID-19 Convalescent Plasma
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID-19 focused on measuring COVID-19 convalescent plasma, convalescent plasma transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Laboratory confirmed COVID-19.
  2. Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure

Exclusion Criteria:

  1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
  2. Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents
  3. Other documented uncontrolled infection
  4. Severe DIC needing factor replacement, FFP, cryoprecipitate
  5. Acute renal failure requiring dialysis
  6. Active intracranial bleeding
  7. Clinically significant myocardial ischemia

Sites / Locations

  • Rutgers New Jersey Medical School
  • University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
July 29, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
University Hospital - Newark, NJ
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1. Study Identification

Unique Protocol Identification Number
NCT04420988
Brief Title
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
Official Title
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
Study Type
Expanded Access

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
University Hospital - Newark, NJ

4. Oversight

5. Study Description

Brief Summary
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
Detailed Description
This expanded access program provides hospitalized patients who are severely or life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma (CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care specialists and Hospitalists identify appropriate patients in accordance with FDA recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP is obtained through New York Blood Center and American Red Cross in coordination with the University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any allergic reactions.Patients admitted to our institution prior to the availability of CCP will be separately reviewed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2, SARS-CoV Infection
Keywords
COVID-19 convalescent plasma, convalescent plasma transfusion

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
COVID-19 Convalescent Plasma
Intervention Description
COVID-19 Convalescent Plasma from recovered COVID-19 patients transfusion into severely or life-threateningly ill COVID-19 infected patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laboratory confirmed COVID-19. Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure Exclusion Criteria: Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents Other documented uncontrolled infection Severe DIC needing factor replacement, FFP, cryoprecipitate Acute renal failure requiring dialysis Active intracranial bleeding Clinically significant myocardial ischemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Klapholz, MD, MBA
Phone
973-972-4595
Email
klapholz@njms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Khyati Mehta, MPH
Phone
973-972-6794
Email
mehtakp@njms.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Klapholz, MD, MBA
Organizational Affiliation
Rutgers New Jersey Medical School; University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Available
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Available

12. IPD Sharing Statement

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Links:
URL
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma
Description
FDA Recommendations for Investigational COVID-19 Convalescent Plasma - April 13, 2020

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Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

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